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Right For Me is a study that aims to improve the conversations patients and health care providers have about birth control. Right For Me will test two different strategies for improving these conversations. The first strategy is to give patients a video to watch that encourages them to ask three specific questions in their health care visit, as well as a prompt card that reminds them of the three questions. The second strategy is to give health care providers a set of decision aids that describe available birth control methods, as well as training in how to use them with patients during the health care visit. Right For Me will test whether introducing one or both of these strategies leads to better conversations than providing health care as usual.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video + Prompt Card | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shared Decision-making About Contraceptive Methods | Shared decision-making about contraceptive methods in the health care visit, measured using the three-item CollaboRATE measure (Barr et al., 2014; Elwyn et al., 2013). We used the version of CollaboRATE with a five-point response scale and adopted the binary scoring approach, which yields a score of 0 (no shared decision-making) and 1 (shared decision-making) for each participant. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants] |
| Measure | Description | Time Frame |
|---|---|---|
| Conversation About Contraception | Whether participants experienced a conversation about contraception in the health care visit, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure to Video | Participants' exposure to the video and timing of exposure, measured using an adapted item (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Thompson, PhD | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Dartmouth Institute for Health Policy and Clinical Practice | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26364752 | Background | Shepherd HL, Barratt A, Jones A, Bateson D, Carey K, Trevena LJ, McGeechan K, Del Mar CB, Butow PN, Epstein RM, Entwistle V, Weisberg E. Can consumers learn to ask three questions to improve shared decision making? A feasibility study of the ASK (AskShareKnow) Patient-Clinician Communication Model((R)) intervention in a primary health-care setting. Health Expect. 2016 Oct;19(5):1160-8. doi: 10.1111/hex.12409. Epub 2015 Sep 14. | |
| 24389354 |
| Label | URL |
|---|---|
| Study Website | View source |
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The investigators will make an anonymized copy of the final participant-level data set and essential analysis syntax available to others for research purposes, either via data sharing on request or via digital repository deposition, before October 2018.
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This was a cluster randomized trial. The level of randomization was clinics.
The recruitment period was April 1, 2016 to December 30, 2016. Recruitment took place in 16 primary care and/or reproductive health care clinics in the Northeast United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Video + Prompt Card | A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. |
| FG001 | Decision Aids + Training | A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter). |
| FG002 | Video + Prompt Card and Decision Aids + Training | A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter). |
| FG003 | Usual Care | Care as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Video + Prompt Card | A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Source: Self-developed. Precise wording of item and response options is available on request. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Shared Decision-making About Contraceptive Methods | Shared decision-making about contraceptive methods in the health care visit, measured using the three-item CollaboRATE measure (Barr et al., 2014; Elwyn et al., 2013). We used the version of CollaboRATE with a five-point response scale and adopted the binary scoring approach, which yields a score of 0 (no shared decision-making) and 1 (shared decision-making) for each participant. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Participants with valid data on the primary outcome of shared decision-making about contraceptive methods and all covariates included in the adjusted analytic model. Data were collected at three time points from samples receiving care before (pre-implementation) and after (post-implementation) introduction of any intervention(s). | Posted | Count of Participants | Participants | Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants] |
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No adverse event data were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Video + Prompt Card | A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. |
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Suboptimal retention at follow-up undermined our power to detect intervention effects on most secondary outcomes.
Modest rates of intervention implementation, according to patient-reported data, should be considered when results are interpreted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Thompson | Dartmouth College | 6036530860 | rachel.thompson@dartmouth.edu |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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|
| Decision Aids + Training | Other |
|
|
| Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] |
| Satisfaction With Conversation About Contraception | Participants' satisfaction with the conversation about contraception in the health care visit, measured using an adapted item (Weisman et al., 2002). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] |
| Intended Contraceptive Method(s) | What, if any, contraceptive method(s) participants intend to use in the next four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] |
| Intention to Use a Highly Effective Contraceptive Method | Whether participants intend to use at least one highly effective contraceptive method in the next four weeks, derived from data on intended contraceptive method(s). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] |
| Values Concordance of Intended Contraceptive Method(s) | Participants' perceptions of the degree of concordance between the contraceptive method(s) they intend(ed) to use and their individual values, needs, and preferences, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (T1); 4 weeks after the index health care visit (Time 2 (T2)); 6 months after the index health care visit (Time 3 (T3)) [for both pre-implementation and post-implementation participants] |
| Decision Regret About Intended Contraceptive Method(s) | Participants' feelings of decision regret about the contraceptive method(s) they intended to use, measured using an adaptation of the five-item Decision Regret Scale (Brehaut et al., 2003; O'Connor, 1996). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] |
| Contraceptive Method(s) Used | What, if any, contraceptive method(s) participants used in the last four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] |
| Use of a Highly Effective Contraceptive Method | Whether participants used at least one highly effective contraceptive method in the last four weeks, derived from data on contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] |
| Use of Intended Contraceptive Method(s) | Whether participants used their intended contraceptive method(s) in the last four weeks, derived from data on intended contraceptive method(s) and contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] |
| Adherence to Contraceptive Method(s) Used | Participants' adherence to the contraceptive method(s) they used in the last four weeks, measured using a self-developed, 21-item measure. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] |
| Satisfaction With Contraceptive Method(s) Used | Participants' satisfaction with the contraceptive method(s) they used in the last four weeks, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] |
| Unintended Pregnancy (Pregnancy Timing Preferences) | Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy timing preferences), measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] |
| Unintended Pregnancy (Pregnancy Seeking) | Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy seeking), measured using an adapted item (Kavanaugh & Schwarz, 2009). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] |
| Unwelcome Pregnancy | Participants' experience of one or more unwelcome pregnancies since the health care visit, measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] |
| Exposure to Prompt Card | Participants' exposure to the prompt card and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] |
| Use of Three Questions | Participants' use of each of the three patient questions in the health care visit, measured using three adapted items (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] |
| Exposure to Decision Aid(s) | Participants' exposure to one or more of the decision aids and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] |
| Acceptability of Video | The acceptability of the video to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] |
| Acceptability of Decision Aid(s) | The acceptability of the decision aid(s) to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] |
| Background |
| Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085. |
| 23768763 | Background | Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12. |
| 11879761 | Background | Weisman CS, Maccannon DS, Henderson JT, Shortridge E, Orso CL. Contraceptive counseling in managed care: preventing unintended pregnancy in adults. Womens Health Issues. 2002 Mar-Apr;12(2):79-95. doi: 10.1016/s1049-3867(01)00147-5. |
| 12926578 | Background | Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005. |
| Background | O'Connor, A. 1996. User Manual - Decision Regret Scale. Ottawa. Retrieved from http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Regret_Scale.pdf |
| Background | Centers for Disease Control and Prevention. 2012. Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 7 Questionnaire: Topic Reference. Atlanta, GA. |
| 20444179 | Background | Kavanaugh ML, Schwarz EB. Prospective assessment of pregnancy intentions using a single- versus a multi-item measure. Perspect Sex Reprod Health. 2009 Dec;41(4):238-43. doi: 10.1363/4123809. |
| 29061624 | Derived | Thompson R, Manski R, Donnelly KZ, Stevens G, Agusti D, Banach M, Boardman MB, Brady P, Colon Bradt C, Foster T, Johnson DJ, Li Z, Norsigian J, Nothnagle M, Olson AL, Shepherd HL, Stern LF, Tosteson TD, Trevena L, Upadhya KK, Elwyn G. Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods. BMJ Open. 2017 Oct 22;7(10):e017830. doi: 10.1136/bmjopen-2017-017830. |
| Ineligible for T2 and T3 |
|
| Lost to Follow-up |
|
| Decision Aids + Training |
A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter). |
| BG002 | Video + Prompt Card and Decision Aids + Training | A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter). |
| BG003 | Usual Care | Care as usual. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Source: Self-developed. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Current Gender Identity | Source: Cahill et al., 2014. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Ethnicity | Source: US Census Bureau, 2015. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Race | Source: US Census Bureau, 2015. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Health literacy | Source: Chew et al., 2008; Chew et al., 2004; Wallace et al., 2006; Dageforde et al., 2015; Sarkar et al., 2011. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Educational attainment | Source: US Census Bureau, 2015. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Health insurance coverage | Source: Jones et al., 2008. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Survey language | Source: Administrative data. | Count of Participants | Participants |
|
| Number of pregnancies | Source: Self-developed. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Number of births | Source: Self-developed. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Number of abortions | Source: Self-developed. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Number of miscarriages | Source: Self-developed. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| Previous contraceptive method(s) | Operationalized as what, if any, contraceptive method(s) participants used in the 4 weeks before the health care visit. Source: Self-developed. Precise wording of item and response options is available on request. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Video + Prompt Card | A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. |
| OG001 | Decision Aids + Training | A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter). |
| OG002 | Video + Prompt Card and Decision Aids + Training | A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter). |
| OG003 | Usual Care | Care as usual. |
|
|
|
| Secondary | Conversation About Contraception | Whether participants experienced a conversation about contraception in the health care visit, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Satisfaction With Conversation About Contraception | Participants' satisfaction with the conversation about contraception in the health care visit, measured using an adapted item (Weisman et al., 2002). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Intended Contraceptive Method(s) | What, if any, contraceptive method(s) participants intend to use in the next four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Intention to Use a Highly Effective Contraceptive Method | Whether participants intend to use at least one highly effective contraceptive method in the next four weeks, derived from data on intended contraceptive method(s). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Values Concordance of Intended Contraceptive Method(s) | Participants' perceptions of the degree of concordance between the contraceptive method(s) they intend(ed) to use and their individual values, needs, and preferences, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1); 4 weeks after the index health care visit (Time 2 (T2)); 6 months after the index health care visit (Time 3 (T3)) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Decision Regret About Intended Contraceptive Method(s) | Participants' feelings of decision regret about the contraceptive method(s) they intended to use, measured using an adaptation of the five-item Decision Regret Scale (Brehaut et al., 2003; O'Connor, 1996). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Contraceptive Method(s) Used | What, if any, contraceptive method(s) participants used in the last four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Use of a Highly Effective Contraceptive Method | Whether participants used at least one highly effective contraceptive method in the last four weeks, derived from data on contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Use of Intended Contraceptive Method(s) | Whether participants used their intended contraceptive method(s) in the last four weeks, derived from data on intended contraceptive method(s) and contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Adherence to Contraceptive Method(s) Used | Participants' adherence to the contraceptive method(s) they used in the last four weeks, measured using a self-developed, 21-item measure. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Satisfaction With Contraceptive Method(s) Used | Participants' satisfaction with the contraceptive method(s) they used in the last four weeks, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Unintended Pregnancy (Pregnancy Timing Preferences) | Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy timing preferences), measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Unintended Pregnancy (Pregnancy Seeking) | Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy seeking), measured using an adapted item (Kavanaugh & Schwarz, 2009). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants |
| Secondary | Unwelcome Pregnancy | Participants' experience of one or more unwelcome pregnancies since the health care visit, measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants] | Participants |
| Other Pre-specified | Exposure to Video | Participants' exposure to the video and timing of exposure, measured using an adapted item (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants |
| Other Pre-specified | Exposure to Prompt Card | Participants' exposure to the prompt card and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants |
| Other Pre-specified | Use of Three Questions | Participants' use of each of the three patient questions in the health care visit, measured using three adapted items (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants |
| Other Pre-specified | Exposure to Decision Aid(s) | Participants' exposure to one or more of the decision aids and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants |
| Other Pre-specified | Acceptability of Video | The acceptability of the video to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants |
| Other Pre-specified | Acceptability of Decision Aid(s) | The acceptability of the decision aid(s) to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant). | Not Posted | Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants] | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Decision Aids + Training | A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Video + Prompt Card and Decision Aids + Training | A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Usual Care | Care as usual. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |
| D008919 | Investigative Techniques |
| No shared decision-making |
|
| Title | Measurements |
|---|---|
| Shared decision-making |
|
| No shared decision-making |
|